Clinical trials: PTA
Chronic Limb-Threatening Ischemia
AcoArt Litos PCB Below-the-knee Global Trial
The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of…
- Trial name
- NCT06330493
- Testing
- PCB, PTA
- Where
- 18 sites in United States, Austria and 1 more
- Volunteers
- 75 people
- Sponsor
- Acotec Scientific Co., Ltd
Peripheral Arterial Disease
STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)
Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter) in…
- Trial name
- ILLUMENATE (NCT01927068)
- Testing
- Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)
- Where
- 44 sites in Australia, Austria and 8 more
- Volunteers
- 499 people
- Sponsor
- Spectranetics Corporation
Multiple Sclerosis, Venous Insufficiency
BRAVE-DREAMS (BRAin VEnous DRainage Exploited Against Multiple Sclerosis)
To assess in a double blinded randomized control trial (RCT) study design safety and effectiveness of balloon angioplasty of the main extracranial and extravertebral veins in multiple sclerosis (MS) associated to chronic…
- Trial name
- BRAVE-DREAMS (NCT01371760)
- Testing
- Venous PTA, Catheter Venography
- Where
- 2 sites in Italy
- Volunteers
- 212 people
- Sponsor
- S. Anna Hospital
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences
Arterio-venous Fistula, Stenosis of Arteriovenous Dialysis Fistula
A First-In-Man Study to Assess Safety and Efficacy of Ultra High Pressure PTA Balloon ULTRAVIOLET in Treating A-V Fistula Stenosis
First-In-Man Single Arm Prospective Study to assess the safety and efficacy of ULTRAVIOLET UHP PTA balloon.
- Trial name
- ULTRAVIOLETFIM (NCT07330817)
- Testing
- PTA balloon
- Where
- Italy
- Volunteers
- 35 people
- Sponsor
- Cardionovum GmbH
Peripheral Vascular Diseases
A Clinical Investigation of SM-01 Stenting Versus PTA for the Treatment of Superficial Femoral Artery Disease
The main objective is to evaluate the safety and efficacy of SM-01 stenting (Cordis S.M.A.R.T.™ Nitinol Stent System) for the treatment of SFA lesions as compared to PTA (balloon angioplasty).
- Trial name
- NCT01183117
- Testing
- SM-01, PTA
- Where
- Japan
- Volunteers
- 105 people
- Sponsor
- Johnson & Johnson K.K. Medical Company
Venous Thromboembolism (VTE)
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
This study is researching an experimental drug called REGN7508 (called "study drug") and will consist of 2 parts: Part 1 and Part 2.
- Trial name
- ROXI-CAT-II (NCT07493304)
- Testing
- REGN7508, Apixaban
- Where
- 13 sites in United States, Bulgaria and 3 more
- Volunteers
- 1,600 people
- Sponsor
- Regeneron Pharmaceuticals
Sensorineural Hearing Loss, Tinnitus
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Background and study aims Hearing problems are becoming more common. In the UK around 18 million adults have hearing loss or hear ringing or buzzing in their ears, which is called tinnitus.
- Trial name
- AHEAD (NCT07895004)
- Testing
- Intelligent PTA, Standard pure-tone audiometry (BSA modified Hughson-Westlake)
- Where
- United Kingdom
- Volunteers
- 84 people
- Sponsor
- University College, London
Post-thrombotic Syndrome, May-Thurner Syndrome
Treadmill Pilot Study (Invasive Pressure Measurements in PTS)
Patients with unilateral post-thrombotic obstruction of the iliac tract and or common femoral vein, eligible for stenting are included. Intravenous pressure is measured in both dorsal foot veins and both common femoral veins.
- Trial name
- NCT01846780
- Testing
- PTA & stenting
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- Maastricht University Medical Center
Patients With Symptomatic Critical Limb Ischemia, Severe Intermittent Claudication
Self Expanding Nitinol Stent Versus Percutaneous Transluminal Arterial Angioplasty (PTA) With Optional Bailout Stenting in Case of PTA Failure in Patients With Symptomatic Critical Limb Ischemia or Severe Intermittent Claudication (EXPAND)
The clinical investigation is a prospective, international, multi-centre, randomized (1:1) trial with follow up investigations at 1, 3, 6 and 12 months.
- Trial name
- EXPAND (NCT00906022)
- Testing
- Astron Pulsar Stent, PTA alone
- Where
- Germany
- Volunteers
- 94 people
- Sponsor
- Biotronik AG
Peripheral Artery Disease
Acotec DCB Post Market Clinical Follow-up
All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical…
- Trial name
- FLOWER (NCT04393389)
- Testing
- AcoArt Orchid (0.035"), AcoArt Tulip (0.018") and AcoArt Litos (0.014") percutaneous transluminal angioplasty (PTA) paclitaxel drug coated balloon catheter manufactured by Acotec Scientific Co., Ltd.
- Where
- 7 sites in Germany
- Volunteers
- 3,000 people
- Sponsor
- Acotec Scientific Co., Ltd
Percutaneous Transluminal Angioplasty, Atherosclerosis of Arteries of the Extremities, Unspecified
Skin Microcirculation in Patients With Lower Limb Atherosclerosis
The aim of this study is to explore the ability of the non-invasive device ODI-Tech® to monitor changes in microvascular blood flow in patients with lower limb ischemia undergoing the procedure percutaneous transluminal…
- Trial name
- SMILLA (NCT07312383)
- Testing
- Examination with the ODI-Tech medical device
- Where
- Norway
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ODI Medical AS
Peripheral Artery Disease
Pilot Study of PRT-201 Following Angioplasty in Patients With Peripheral Artery Disease (PAD)
The purpose of this study is to determine if it is safe and feasible to apply PRT-201 to the adventitia of arteries following successful angioplasty (PTA).
- Trial name
- NCT01616290
- Testing
- PRT-201
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Proteon Therapeutics
Peripheral Artery Disease
PMCF Study for Peripheral Arteries Below the Knee (BTK)
The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-word population of 100 patients who underwent an endovascular intervention within standard-of-care (SOC)…
- Trial name
- NCT05444660
- Where
- 5 sites in Austria, Germany
- Volunteers
- 102 people
- Sponsor
- Cordis US Corp.
Dental Caries
On Probiotic, Dental Caries, and Orthodontic Patients
To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients. Shortage on testing the effect of probiotic on Orthodontic patients can be seen on litterateurs making a gap of whether is…
- Trial name
- NCT04593017
- Testing
- Active Probiotic
- Where
- Sweden
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Göteborg University
Peripheral Artery Disease, Arterial Disease of Legs
ABLUMINUS DES BTK Registry - FIM
A prospective, single center, single arm non-randomized trial collecting safety and effectiveness data for the ABLUMINUS DES System to treat BTK lesions in subjects with CLI.
- Conditions
- Peripheral Artery Disease, Arterial Disease of Legs, Atherosclerosis
- Trial name
- NCT04562740
- Testing
- ABLUMINUS DES drug eluting stent
- Where
- Singapore
- Volunteers
- 30 people
- Sponsor
- Concept Medical Inc.
Peripheral Arterial Disease, Peripheral Vascular Disease
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon
To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Disease, Artery Disease, Peripheral, Femoropopliteal Artery Occlusion
- Trial name
- TRANSCEND (NCT03241459)
- Testing
- Surmodics SurVeil DCB, Medtronic IN.PACT Admiral DCB
- Where
- 63 sites in United States, Australia and 7 more
- Volunteers
- 446 people
- Sponsor
- SurModics, Inc.
Arteriovenous Fistula
Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae
The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm.
- Trial name
- AVR (NCT02746159)
- Testing
- Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004
- Where
- 26 sites in Austria, France and 11 more
- Volunteers
- 320 people
- Sponsor
- C. R. Bard
Ischemia, Peripheral Arterial Disease (PTA
The ABSORB Bioresorbable Scaffold Below the Knee (BTK) Study
ABSORB BTK Study: A prospective, multicenter, controlled clinical evaluation of the use of a bioresorbable drug eluting stent in the arterial vasculature below the knee
- Conditions
- Ischemia, Peripheral Arterial Disease (PTA, Arterial Occlusive Diseases
- Trial name
- NCT02793349
- Testing
- Absorb Bioresorbable Vascular Scaffold
- Where
- 4 sites in Australia, Netherlands and 1 more
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- The University of New South Wales
Acute Diverticulitis
Supplementation With Lacobacillus Reuteri ATCC PTA 4659 in Patients Affected by Acute Uncomplicated Diverticulitis
Acute Uncomplicated Diverticulitis (AUD) is defined as inflammation of the colon diverticulum, often involving the colic wall and pericolic fat.
- Trial name
- NCT03656328
- Testing
- Lactobacillus Reuteri 4659
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS